MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® INSTANT TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Lot Number 301952

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

It was reported that the patient was hospitalized for diabetic ketoacidosis while using the blood glucose monitor.On (b)(6) 2023, the blood glucose monitor displayed a test strip error message at an unknown time.On (b)(3) 2023, the patient was hospitalized due to diabetic ketoacidosis.The patient was unable to use the blood glucose monitor on the day of the event.The blood glucose results at the hospital were not provided.The patient was treated for diabetic ketoacidosis.The type of treatment provided was unknown.The patient was released from the hospital on (b)(3) 2023.

• Brand Name: ACCU-CHEK ® INSTANT TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18291056
• MDR Text Key: 330045951
• Report Number: 3011393376-2023-02758
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 301952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female